The total HIV positive patient population worldwide is in excess of 40 million. The vast majority of individuals living with this disease are in resource poor environments where conventional CD4+ T cell enumeration is both too expensive to perform and technically challenging, due to a paucity of trained personnel. Treatment efforts currently underway, such as the World Health Organizations “3 by 5” Initiative, will be providing access to HAART (e.g. highly active anti-retroviral therapy) to millions of patients in these areas of the world over the next several years. It is in such resource-poor environments where CD4 counts are arguably the most important to perform. Current costs and assay complexities limit this. An accurate CD4 count can be employed: to facilitate AIDS surveillance; to monitor the rate of progression to AIDS, to define when therapy is required to prevent opportunistic infections, to place drug-naive patients into cohorts prior to therapy, and to monitor the effects of anti-retroviral therapy (c.f. Jani et al., 2001, 2002; affordCD4.com, Bendavid et al., 2008). It is currently recommended that a CD4 assay should be performed on every HIV-infected individual every 3-6 months (MMWR; 1997; 46:1) and more frequently depending on circumstance. Current available test are costly and require trained personnel to perform, generating a worldwide need for cheaper and simpler tests and assay methods.
In view of the aforementioned deficiencies and costs attendant with prior art assays and methods of manufacturing assays, it should be apparent that there exists a need in the art for simple, rapid, highly sensitive, and low cost lateral flow based assays as well a method to manufacture and analyze the results quickly and at low cost without the requirement of on site highly skilled personnel. The assay described here is intended to answer this need, both from the standpoint of addressing the technical difficulties and the requirement for low cost.
The citation of references herein shall not be construed as an admission that such is prior art to the present invention.